The US Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance, expanding its scope to devices that will improve accessibility and promote health equity once finalized.
Specifically, the draft guidance clarifies the considerations in designating devices, including devices that may benefit populations impacted by disparities in health and healthcare. The document also includes discussions how the FDA intends to disclose the Breakthrough Device status once the device obtains marketing authorization for an indication for use consistent with its Breakthrough Device designation…
